[Federal Register Volume 90, Number 76 (Tuesday, April 22, 2025)]
[Notices]
[Pages 16881-16888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06882]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 24-32]
Svetlana Burtman, N.P.; Decision and Order
I. Introduction
On December 28, 2023, the then-Administrator issued an Order to
Show Cause and Immediate Suspension of Registration (OSC/ISO) to
Svetlana Burtman, N.P., of Tucson, Arizona (Respondent). OSC/ISO, at 1.
The OSC/ISO informs Respondent of the immediate suspension of her Drug
Enforcement Administration (DEA or Government) Certificate of
Registration, No. MB2645767, pursuant to 21 U.S.C.
[[Page 16882]]
824(d), alleging that Respondent's continued registration constitutes
``an imminent danger to the public health or safety.'' Id. (quoting 21
U.S.C. 824(d)). The OSC/ISO also proposes the revocation of
Respondent's registration, No. MB2645767, as well as the denial of
Respondent's application for a new registration for her Green Valley
clinic (GVC), No. W23106194M, alleging that Respondent's registration
is inconsistent with the public interest. Id. at 1-2.
More specifically, the OSC/ISO alleges that Respondent (1)
dispensed controlled substances from an unregistered location, in
violation of 21 CFR 1301.12(a) (a separate registration is required for
each principal place of business or professional practice where
controlled substances are dispensed), (2) failed to maintain, readily
retrievable from her ordinary business records, a complete and accurate
record of each controlled substance received, in violation of 21 U.S.C.
827(a)(3) and 827(b) and 21 CFR 1304.04(a) and 1304.21(a), and (3)
failed to maintain the requisite dispensing logs, in violation of 21
CFR 1304.22(c).\1\ OSC/ISO, at 2-4.
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\1\ The OSC/ISO also alleges violations of Arizona law, none of
which the Agency is adjudicating due to the seriousness of the
alleged federal violations. Each of the alleged federal violations
alone, if proven, is a sufficient basis to revoke Respondent's
registration and deny her registration application.
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Respondent requested a hearing.\2\ The hearing was held before
Chief Administrative Law Judge, John J. Mulrooney, II, (Chief ALJ) who,
on June 20, 2024, issued his Recommended Rulings, Findings of Fact,
Conclusions of Law, and Decision of the Administrative Law Judge (RD).
The RD recommends that Respondent's Tucson registration be revoked and
that her application for a GVC registration be denied. RD, at 35-36. On
July 10, 2024, Respondent timely filed ``Exceptions to ALJ
Recommendations'' (Exceptions). Eleven exceptions challenge the RD's
Conclusions of Fact, and four challenge the RD's Conclusions of Law.\3\
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\2\ The Agency agrees with the final rulings contained in the
Order Regarding the Government's Motions In Limine and for Partial
Summary Disposition (May 9, 2024).
\3\ The Agency carefully considered each of Respondent's
Exceptions. Infra.
Respondent's first factual Exception concerns ``Conclusions
Regarding the 2021 Investigation'' and states, in essence, that the
Chief ALJ wrongly denied Respondent the opportunity to present one
of the several attorneys who represented her during the ``2021
Investigation'' as a rebuttal witness. Exceptions, at 4. That
rebuttal witness, according to the first factual Exception, would
testify that the United States Attorney's Office ``never informed
[him] of any purported regulatory violations arising from the 2021
visit.'' Id. at 5. Accordingly, the first factual Exception
continues, Respondent ``had a reasonable belief that her storage and
record-keeping practices were compliant following the 2021 visit.''
Id.
The Agency rejects Respondent's first factual Exception. The
violations alleged in the OSC/ISO do not date back to 2021, and
matters dating back to 2021 are not factually relevant to the
Agency's adjudication of the allegations. Further, the Agency
rejects Respondent's theory that, if a registrant's ``storage and
record-keeping practices'' are compliant in one year, the registrant
may maintain a ``reasonable belief'' that she will remain compliant
going forward regardless of changes in the registrant's practices or
without the registrant continuously monitoring for required changes.
The content of Respondent's first factual Exception, however,
indicates a pattern of Respondent's failure to follow up with DEA
staff about their encounters. Infra. section V.
Respondent's fourth factual Exception states that the
Government's case wrongly claims that Respondent had ``6 mg
Testosterone pellets at the GVC,'' because ``no such formulation
exists in the record.'' Id. at 8-9. As the Agency's Decision and
Order does not mention, let alone rely on, the Exception's alleged
factual inaccuracy, the Agency rejects Respondent's fourth factual
Exception.
Respondent's second, fifth, sixth, seventh, and eleventh factual
Exceptions concern the credibility of record evidence. The second
factual Exception challenges the credibility of a DEA Investigator's
testimony about whether Respondent said that she ``did not plan on
conducting regulated activities'' at GVC. Id. at 6. The fifth
factual Exception attacks the credibility of ``aspects'' of the DEA
Investigator's testimony that the Exception admits have ``limited
significance to the Chief ALJ's recommendations.'' Id. at 9-10. The
sixth factual Exception concerns the Chief ALJ's
``characterization'' of Respondent's testimony about the ``storage
of controlled substances at GVC'' as ``inconsistent and fatal to her
credibility.'' Id. at 10-12. The seventh factual Exception concerns
the Chief ALJ's ``[r]eference to [a] [n]on-[e]xistent August 9, 2023
[v]isit [f]rom the D[EA] Audit Team.'' Id. at 12-13. And the
eleventh factual Exception, like the sixth factual Exception,
concerns the Chief ALJ's recommendation that, when there is a
conflict, the DEA Investigator's testimony should be credited, not
Respondent's testimony. Id. at 16-17.
The Agency carefully evaluated each of these five factual
Exceptions. As discussed in this Decision and Order, the Agency's
found facts are based on Respondent's own testimony, on Respondent's
own evidence, and/or on evidence that Respondent does not contest.
Accordingly, Respondent's second, fifth, sixth, seventh, and
eleventh factual Exceptions play no role in the Agency's
adjudication of the OSC/ISO's allegations and, therefore, the Agency
rejects them.
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Having carefully reviewed the entire record, the Agency agrees with
the RD's recommended sanction of (1) revocation of Respondent's
registration and (2) denial of Respondent's GVC registration
application.
II. The Alleged Violations
As already discussed, the OSC/ISO alleges that Respondent violated
multiple provisions of the Controlled Substances Act (CSA) and its
implementing regulations.\4\ As the Supreme Court stated in Gonzales v.
Raich, the ``main objectives of the CSA were to conquer drug abuse and
to control the legitimate and illegitimate traffic in controlled
substances. Congress was particularly concerned with the need to
prevent the diversion of drugs from legitimate to illicit channels.''
545 U.S. 1, at 12-13 (2005). The Supreme Court further explained that,
to accomplish its objectives, ``Congress devised a closed regulatory
system making it unlawful to . . . dispense[ ] or possess any
controlled substance except in a manner authorized by the CSA.'' Id. at
13. Accordingly, the Supreme Court stated, the ``CSA and its
implementing regulations set forth strict requirements regarding
registration, . . . drug security, and recordkeeping.'' Id. at 14; see
also Gonzales v. Oregon, 546 U.S. 243, 266 (2006) (``Law enforcement
decisions respecting the security of stocks of narcotic drugs and the
maintenance of records on such drugs are to be made by the Attorney
General.'').
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\4\ The OSC/ISO also mentions 21 U.S.C. 1301.71 and 1301.75.
OSC/ISO, at 3. The Government's Proposed Findings of Fact,
Conclusions of Law, and Argument (Closing Brief), however, does not
mention either of these provisions, apparently abandoning them.
Accordingly, the Agency is not adjudicating them and they are not
sustained.
The OSC/ISO also mentions 21 U.S.C. 1301.72(b)(8)(ii) (``Non-
controlled drugs, substances and other materials may be stored with
Schedule III through V controlled substances in any of the secure
storage areas required by 21 CFR 1301.72(b), provided that
permission for such storage of non-controlled items is obtained in
advance, in writing, from the Special Agent in Charge of DEA for the
area in which such storage area is situated.''). OSC/ISO at 3. The
Government's Closing Brief addresses this provision. It does so,
however, in only one sentence, followed by a cite to four lines of
the transcript about Respondent's registered Tucson location. The
Agency finds that the Government did not submit substantial evidence
that Respondent violated 21 U.S.C. 1301.72(b)(8)(ii) and, therefore,
the Agency does not sustain the 21 U.S.C. 1301.72(b)(8)(ii)
allegation.
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The OSC/ISO's allegations concern the CSA's ``strict requirements
regarding registration . . . and recordkeeping'' and, therefore, go to
the heart of the CSA's ``closed regulatory system'' specifically
designed ``to conquer drug abuse and to control the legitimate and
illegitimate traffic in controlled substances,'' and ``to prevent the
diversion of drugs from legitimate to illicit channels.'' 545 U.S. at
12-14.
A. Dispensing Controlled Substances From an Unregistered Location (21
CFR 1301.12(a))
First, the OSC/ISO alleges that Respondent dispensed controlled
substances from GVC, an unregistered location. OSC/ISO, at 2-4.
According to the applicable CSA regulation, ``[a] separate registration
is required for each principal place of business or professional
practice at one general physical location where controlled substances
are . . . dispensed by a
[[Page 16883]]
person.'' 21 CFR 1301.12(a).\5\ Further, ``dispense'' means ``to
deliver a controlled substance to an ultimate user . . . including the
prescribing and administering of a controlled substance.'' 21 U.S.C.
802(10).
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\5\ See also 21 U.S.C. 822(e)(1). The OSC/ISO does not allege a
violation of the statutory provision, so the statutory provision
plays no role in the Agency's adjudication.
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The Agency finds no merit to Respondent's argument that the
separate registration requirement is confusing, and that its
application to her practice is ``unclear.'' Her argument relies on
guidance documents and other materials applicable to registrants who
travel to patients' locations to provide medical treatment (such as
patients' homes and, for animals, stables). Those materials do not
apply to registrants, such as herself, who transport controlled
substances from a practice location that is registered to another
practice location that is not registered. For a practitioner such as
Respondent, whose business model is to practice at brick and mortar
locations to which patients come for medical treatment, the meaning and
application of these provisions are clear.\6\ Jeffery J. Becker, D.D.S.
v. Drug Enf't Admin., 541 F. App'x 587, 590 (6th Cir. 2013) (``We have
no occasion to disturb . . . [the Deputy Administrator's] determination
that Becker's claim of reasonable confusion or mistake was not
credible.''); United States v. Clinical Leasing Service, Inc., 925 F.2d
120, 121-23 (5th Cir. 1991) (concluding that ``each principal place of
business'' is not unconstitutionally vague).\7\
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\6\ It is Respondent's first Exception to the ALJ's Conclusions
of Law that argues that there is confusion about the ``separate
registration'' requirement. Exceptions, at 18-20. To support her
claim of confusion, she cites a Diversion Control Division
``Guidance Document'' titled ``Practice of Medicine'' whose
``Question'' asks ``Can a physician transport controlled substances
and administer at the patient's home residence (the so-called `black
bag exception')?'' EO-DEA212, DEA-DC-047, October 8, 2020.
Respondent does not explain how this Guidance Document clearly
addressing the administering of controlled substances ``at the
patient's home'' pertains to and, therefore, confuses her about her
transporting to, and administering of controlled substances at, her
GVC location, which is not a residence, let alone a ``patient's
home.'' The Agency finds unpersuasive Respondent's confusion defense
based on this Guidance Document and rejects this aspect of her first
legal Exception.
Respondent's first legal Exception, to support her argument that
the separate registration requirement is unclear, also cites a
proposed rulemaking titled ``Principal Place of Business or
Professional Practice,'' RIN: 1117-AB52, DEA Docket number 474, Fall
2023.'' Exceptions, at 18-19. To date, this proposed rulemaking
remains in the most incipient stages and explicitly states, similar
to the purpose of the so-called ``Black Bag'' exception, that it
concerns ``allow[ing] a broader range of practice for practitioners
traveling to administer controlled substances.'' Id. As Respondent,
herself, testified, however, she intends the GVC to be a brick and
mortar clinic like her Tucson clinic. Tr. 303 (Respondent testifying
that she ``wanted to have[ ] pellets that designated to Green Valley
office so when . . . [she] get[s her] license, . . . [she] would be
able to order specifically to Green Valley location and keep the
logs at Green Valley office pertaining to that office only, and
separate . . . [her] inventory. And in terms of business, . . .
[she] wanted to see what location does what and how it is going.'').
In other words, Respondent plans for her patients to travel to GVC
for treatment; she does not plan to travel to patients' homes. Tr.
282-84 (Respondent testifying that she first decided to open a
clinic in Green Valley in 2021, and that ``[t]here is nothing
similar or like it in Green Valley, and there is a high demand for
that type of medicine . . . . People would drive to Tucson from
Green Valley, asking to bring something like that into Green
Valley.''). Accordingly, the Agency disagrees with Respondent's
argument in her first legal Exception that a DEA proposed rulemaking
supports her claim that the separate registration requirement, as
applied to her medical practice, is unclear. The Agency rejects
Respondent's first legal Exception in its entirety.
\7\ Jeffery J. Becker, D.D.S. and Jeffery J. Becker, D.D.S.
Affordable Care, 77 FR 72,387, 72,387-88 (2012) (``[T]he statute
provides clear notice that it is the activity of dispensing, which
includes the administration of controlled substances, itself, which
triggers the requirement, in the case of a practitioner, of
obtaining a separate registration for a principal place of
professional practice . . . . To the extent Respondent suggests that
the Expert's testimony establishes that there is widespread
confusion among practitioners as to the scope of the registration
requirements, the argument is unavailing. The clarity of the Act and
the Agency's regulations is not determined by whether there are even
a substantial number of members of the dental profession in Ohio who
are confused as to the scope of the registration requirements.
Rather, it is determined by assessing whether the text of the Act
and regulations provide fair notice such that a person of ordinary
intelligence can understand when a separate registration is
required. See FCC v. Fox Television Stations, Inc., . . . [267 U.S.
239] (2012) (quoting United States v. Williams, 553 U.S. 285, 304
(2008)). The Act and regulations pass this test with flying colors .
. . . While the record establishes that the Government's Expert
travels to numerous offices of other dentists to provide anesthesia
services for their patients, he does so on an apparently as-needed
and random basis, and there is no evidence that he maintains a place
of professional practice, let alone a principal one, at any of these
locations.'').
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B. Failing To Maintain, Readily Retrievable From Her Ordinary Business
Records, at Respondent's Tucson Clinic a Complete and Accurate Record
of Each Controlled Substance Received (21 U.S.C. 827(a)(3) and 827(b)
and 21 CFR 1304.04(a) and 1304.21(a))
Second, the OSC/ISO alleges that Respondent failed to maintain,
readily retrievable from her ordinary business records, a complete and
accurate record of each controlled substance she received. OSC/ISO, at
3; see 21 U.S.C. 827(a)(3) and 827(b) and 21 CFR 1304.04(a) and
1304.21(a). According to the CSA and its implementing regulations,
``every'' registrant who dispenses a controlled substance ``shall
maintain, on a current basis, a complete and accurate record of each
such substance . . . received . . . or otherwise disposed of by him . .
. except that this paragraph shall not require the maintenance of a
perpetual inventory.'' 21 U.S.C. 827(a)(3); see also 21 CFR 1304.21(a)
(``Every registrant required to keep records pursuant to Sec. 1304.03
shall maintain, on a current basis, a complete and accurate record of
each substance . . . received . . . or otherwise disposed of by him/
her, and each inner liner, sealed inner liner, and unused and returned
mail-back package, except that no registrant shall be required to
maintain a perpetual inventory.'').
C. Failing To Maintain the Required Dispensing Logs for Respondent's
Tucson Clinic (21 CFR 1304.22(c))
Third, the OSC/ISO alleges that Respondent failed to maintain the
required controlled substance dispensing logs for her Tucson location.
OSC/ISO, at 3. According to the CSA's implementing regulations, a
dispenser is to maintain records of, among other things, the ``number
of units or volume of such finished form dispensed, including the name
and address of the person to whom it was dispensed, the date of
dispensing, the number of units or volume dispensed, and the written or
typewritten name or initials of the individual who dispensed or
administered the substance on behalf of the dispenser.'' \8\ 21 CFR
1304.22(c).
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\8\ A dispenser is also required to ``maintain records with the
same information required of manufacturers'' pursuant to paragraph
(a)(2)(i), (ii), (iv), (vii), and (ix) of this section.'' 21 U.S.C.
1304.22(c).
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III. Findings of Fact
A. Dispensing Controlled Substances From an Unregistered Location (21
CFR 1301.12(a))
The Agency finds substantial, uncontroverted record evidence that
Respondent's GVC is not, and never has been, a registered location. GX
9 (Respondent's Form 224 GVC registration application showing the
submission date as July 19, 2023); Tr. 300 (Respondent testifying that
she thought DEA would approve her GVC registration application
``quickly,'' but ``[i]t didn't happen at all''). The Agency finds
substantial record evidence that Respondent admitted that she
transported controlled substances to GVC, an unregistered location, and
that she dispensed controlled substances there by administering them
directly to individuals. E.g., Stipulation Order, at 3 (Stipulation No.
18: ``The logs and patient records indicated that Respondent dispensed
testosterone
[[Page 16884]]
pellets/injections between July 1, 2021, and September 18, 2023, to at
least eight patients at the unregistered Green Valley Clinic
location.''); Tr. 285 (Respondent testifying that she transported
controlled substances from her Tucson location to GVC), Tr. 292, 297
(Respondent testifying that she administered controlled substances to
individuals at GVC); see also GX 13 and GX 14 (GVC dispensing logs).\9\
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\9\ Respondent's ninth factual Exception concerns the ``ALJ's
conclusion that . . . [Respondent] administered controlled
substances at the GVC after the . . . [DEA Investigators] left on
July 19, 2023.'' Exceptions, at 14. This factual Exception further
states that the ``ALJ rejected . . . [Respondent's] correction to
the hearing transcript, which refutes the conclusion on page 13 [of
the RD] that she ``administered controlled substances [at GVC]
shortly after the . . . [DEA Investigators] departed.'' Id.
The Agency carefully considered Respondent's ninth factual
Exception. The Agency rejects it because the precise timing of
Respondent's July 19, 2023 GVC dispensing of controlled substances
plays no role in this adjudication.
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The Agency also finds substantial record evidence that Respondent
admitted that she told DEA Investigators that she did not ``dispense''
controlled substances from GVC. E.g., Tr. 291 (Respondent testifying
that the DEA Investigators asked her if she ``dispensed'' controlled
substances from GVC and that her answer was ``no'').\10\ The Agency
finds substantial record evidence that Respondent's denial that she
``dispensed'' controlled substances from GVC was premised on her use of
an incorrect meaning of the word ``dispense.'' \11\ Tr. 292 (Respondent
testifying that ``dispense,'' ``in . . . [her] mind,'' is ``something
that occurs with shipping to you and . . . you account for the drug at
that location. That only was happening at Tucson.''), see also Tr. 342-
43 (Respondent testifying that she understands ``dispensing'' to mean
``receiving and dispensing drugs out of that location'' and that giving
testosterone to a patient to take home ``could be one of the
instances''); cf. supra section II.A. (CSA definition of ``dispense'');
see GX 13 and GX 14 (GVC liquid testosterone and testosterone pellet,
respectively, ``dispensing'' logs from July 2021 through September 18,
2023).
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\10\ But see Stipulation Order, at 3 (Stipulation No. 23: ``On
November 6, 2023, under oath, the Respondent was asked the following
question and provided the following answer (Tr. 51:8-18):
Q: So when I asked you specifically why you had controlled
substances at a non-registered location you stated to me that you
were prepping the office. Does that sound accurate to you?
A: I have patients that travel from Tucson to Green Valley
location and from Green Valley location to Tucson based on where I'm
working, which kind of defeats the purpose of having my two clinics.
So, say a patient that comes to Green Valley is from Tucson that was
allowed to be dispensed, so this was my train of thought that I was
carrying the controlled substances with me.'');
Stipulation Order, at 4 (Stipulation No. 24: ``On November 6,
2023, under oath, the Respondent was asked the following question
and provided the following answer (Tr. 53:9-15):
Q: Okay. So upon reviewing your controlled substance dispensing
logs for the Green Valley location when we did the administrative
inspection warrant on September 20, 2023, you had, you were
administering controlled substances at an unregistered location
since prior to DEA's visit on July 19th; is that true?
A: Yes.''); and
Stipulation Order, at 4 (Stipulation No. 25: ``On November 6,
2023, under oath, the Respondent was asked the following question
and provided the following answer (Tr. 54:14-19):
Q: Okay. So my question to you: Were you just administering
controlled substances at the Green Valley location that was not a
DEA registered location?
A: I was, but they were also patients in Tucson. They would come
to Tucson just like they come to Green Valley.'').
\11\ Respondent's eighth factual Exception states that
Respondent's ``testimony regarding the distinction she held in her
mind between administering and dispensing was not offered as a
defense to the allegations here, but rather as an explanation for
her state of mind at the time of the July 19, 2023 conversation with
investigators . . . . She felt that she was not dispensing.''
Exceptions, at 13-14. The exception also states that Respondent's
response was ``deemed by the . . . [DEA Investigators] and ALJ to
have been a lie.'' Id. at 14.
The Agency carefully considered Respondent's eighth factual
Exception and notes the reference to Respondent's ``state of mind''
on July 19, 2023. This Decision and Order does not conclude that
Respondent's ``distinction between administering and dispensing''
was, or was not, a lie. Instead, Respondent's clear failure to
understand and adopt the statutory definitions of ``dispense'' and
``administer'' is relevant to whether the Agency can re-entrust
Respondent with her Tucson registration and issue her a registration
for GVC. 21 U.S.C. 802(2) and 802(10); infra section V.
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Further, the Agency finds substantial, uncontroverted record
evidence that DEA Investigators told Respondent and Respondent knew
that she needs a registration to dispense or administer controlled
substances at GVC. Stipulation Order, at 2 (Stipulation No. 11: ``On or
about July 19, 2023, DEA investigators informed the Respondent that in
order to handle, dispense, and/or administer controlled substances at
the Green Valley Clinic location she would have to apply for a separate
DEA C[ertificate] O[f] R[egistration] for that address.''); Tr. 294-95
(Respondent testifying that, on July 19, 2023, the DEA Investigators
told her that she needed a registration to administer controlled
substances at GVC); Stipulation Order, at 2 (Stipulation No. 14); GX 9
(Respondent's GVC registration application showing the submission date
of July 31, 2023).
Despite her admission that, on July 19, 2023, she knew that she
needed a registration to dispense or administer controlled substances
from GVC, Respondent took about 12 days, or almost two weeks, to submit
an electronic application for a GVC registration. Supra. Further,
although she knew that it was unlawful to ``handle, dispense, and/or
administer'' controlled substances from an unregistered location, the
Agency finds uncontroverted, substantial record evidence that
Respondent continued to do so into September of 2023. Supra Stipulation
Order, at 2 (Stipulation No. 11); GX 13 and GX 14. Indeed, according to
her own records, Respondent dispensed controlled substances from GVC at
least seventy-one times on and after July 19, 2023.\12\ GX 13, at 7-9
(showing 43 liquid testosterone dispensings at GVC from July 19, 2023
to September 18, 2023), GX 14, at 9-10 (showing 28 testosterone pellet
dispensings at GVC from July 19, 2023 to September 19, 2023). Further,
Respondent testified that she continued to handle controlled substances
at GVC, in essence, for her convenience. Tr. 309 (Respondent testifying
that she ``learned that it's absolutely not okay'' to ``draw up''
``halfway empty, at least most empty,'' controlled substance vials at
GVC because she had ``more time [on September 20, 2023] at Green Valley
than at Tucson to do that'').
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\12\ During the approximately nine weeks between July 19 and
about September 19, Respondent worked at GVC ``at least once a
week,'' although ``[o]ccasionally, it was not even once a week, it
was once every two weeks.'' Tr. 284. This means that, based on her
own testimony, Respondent administered controlled substances at GVC
to an average minimum of about eight people per day for each of
those nine weeks.
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Accordingly, the Agency finds substantial record evidence that
Respondent dispensed controlled substances from GVC, an unregistered
location, for over two years. Tr. 306 (Respondent testifying and
admitting that GVC never had, and still does not have, a registration).
Thus, having read and analyzed all of the record evidence, the
Agency finds substantial record evidence, in the forms of stipulations
and Respondent's hearing testimony and documentary admissions, of each
element of the allegation that Respondent dispensed controlled
substances from her GVC unregistered location. Supra.
B. Failing To Maintain, Readily Retrievable From her Ordinary Business
Records at Respondent's Tucson Clinic, a Complete and Accurate Record
of Each Controlled Substance Received (21 U.S.C. 827(a)(3) and 827(b)
and 21 CFR 1304.04(a) and 1304.21(a))
The Agency finds substantial record evidence that, on July 19,
2023, Respondent signed a Notice of
[[Page 16885]]
Inspection of Controlled Premises consenting to the inspection of her
Tucson facility on that same day. GX 5; Stipulation Order, at 2
(Stipulation No. 12''); Tr. 295. The Agency finds substantial record
evidence that Respondent suggested that the DEA Investigators ``work
with her [Tucson] office lead,'' CO. Tr. 43-44 (DEA Investigator
testifying). The Agency finds substantial record evidence that CO
represented to be ``willing and able to provide . . . [the DEA
Investigators] whatever records . . . [they] requested.'' Id. at 45
(DEA Investigator testifying).
The Agency finds substantial record evidence that the DEA
Investigators asked CO for, but did not receive, a complete and
accurate record of each controlled substance that Respondent received
at her Tucson clinic. Tr. 47, 61-62 (DEA Investigator testifying).\13\
The Agency finds substantial record evidence that CO told DEA
Investigators that she was ``unable to retrieve the records on the
spot'' because Respondent changed her ``computer systems twice in . . .
[the] past year.'' \14\ Id. at 61 (DEA Investigator testifying).
Accordingly, the Agency finds substantial record evidence that the DEA
Inspection Team never received Respondent's Tucson purchase invoice
records.\15\ Id. at 234-35. Further, the Agency finds no record
evidence that Respondent contests that the DEA Inspection Team never
received her Tucson purchase invoice records.\16\ Finally, the Agency
finds no record evidence that Respondent proffered at the hearing any
of the Tucson controlled substance-received records that the DEA
Inspection Team requested, but did not receive. E.g., Int'l Union,
United Auto., Aerospace & Agric. Implement Workers of Am. (UAW) v.
Nat'l Labor Relations Bd., 459 F.2d 1329, 1336 (D.C. Cir. 1972)
(``Simply stated, the rule provides that when a party has relevant
evidence within his control which he fails to produce, that failure
gives rise to an inference that the evidence is unfavorable to him.'');
see also Huthnance v. District of Columbia, 722 F.3d 371, 378 (D.C.
Cir. 2013) (same).
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\13\ CO did, however, provide dispensing logs. Infra.
\14\ CO stated, though, that she could obtain ``purchase invoice
records'' for the DEA Inspection Team ``from the supplier'' even
though she did not have ``any on hand to provide'' to the
investigators. Id. at 62 (DEA Investigator testifying). The Agency
finds no record evidence, however, that CO obtained the Tucson
clinic purchase invoice records from the supplier and gave them to
the DEA Inspection Team. See also Tr. 227-28 (DEA Investigator
testifying and explaining that suppliers' records about registrants'
controlled substance purchases are insufficient to show that the
registrant actually received the controlled substances).
\15\ The Agency finds substantial record evidence that the DEA
Investigator explained to CO that ``in order to do a complete audit
we required all the documents that we were requesting, and because
we were unable to get the full scope of documents, we weren't able
to complete a full audit.'' Tr. 62-63.
\16\ Respondent's third factual Exception challenges the
credibility of the DEA Investigator's testimony that Respondent was
given the opportunity to supplement missing records following the
inspection of the Tucson clinic. The Agency carefully considered
this exception. It rejects the exception because this adjudication
does not require a finding of whether the DEA Inspection Team asked
Respondent for the missing records. Instead, the germane finding,
which Respondent does not contest, is that Respondent's Tucson
clinic's controlled substance purchase invoice records were not
readily available to the DEA Inspection Team. Indeed, the DEA
Inspection Team never received those records.
Further, and of relevance to this adjudication, Respondent's
testimony does not evidence an interest in, or concern about, the
inspection of her Tucson clinic. For example, immediately after
testifying that CO was present for the Tucson inspection, Respondent
declined to provide a substantive answer to the question her counsel
asked: ``And what did you learn of what happened at the inspection
at the Tucson clinic on July 19?'' Tr. 297. Instead of answering,
Respondent stated: ``Ask me another question. So much happened.''
Id. In other words, while the substantial record evidence is that
Respondent voluntarily, on the day of the inspection, provided her
in-person agreement to the DEA inspection of her Tucson facility,
the Agency finds no record evidence that Respondent took the
initiative to contact any member of the DEA Inspection Team or her
own staff, whose identities she knew, to take any follow-up steps
after DEA's inspection of her Tucson clinic. See id.
---------------------------------------------------------------------------
Having read and analyzed all of the record evidence, the Agency
finds substantial record evidence, uncontested by Respondent, of each
element of the allegation that Respondent failed to maintain, readily
retrievable from her ordinary business records at her Tucson clinic, a
complete and accurate record of each controlled substance received.
Supra.
C. Failing To Maintain the Required Dispensing Logs for the Tucson
Clinic (21 CFR 1304.22(c))
The Agency finds substantial record evidence that Respondent
maintained insufficient records of controlled substances that she
dispensed at her Tucson clinic.\17\ GX 6, for example, shows
Respondent's dispensing of testosterone at her Tucson clinic from June
28, 2023 to July 19, 2023. Id. GX 6, however, only shows the ``dispense
date,'' the ``patient name,'' the ``DOB,'' the ``dose,'' and the ``MA
Initial's'' [sic]. It does not show the size or number of milligrams in
the containers ``opened'' and dispensed, the form of the controlled
substance, the patient address, or more than a month of dispensing. Tr.
338 (Respondent testifying), id. at 67 (DEA Investigator testifying
that GX 6 is ``missing the drug strength, form, patient address, and it
only encompasses less than a month of dispensing''); see also GX 7
(same for the record of Phentermine dispensed at Respondent's Tucson
clinic); RX D (records of testosterone dispensed at Respondent's Tucson
clinic with the more recent pages improved to show the patient's
address).
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\17\ The data that must be included in a controlled substance
dispensing log are discussed in section II.C., supra.
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The Agency further finds substantial record evidence that parts of
Respondent's hearing testimony admit that both liquid testosterone and
testosterone pellets come in various strengths. Thus, Respondent knows
that there are different strengths of those controlled substances, but
did not include that information in her records of Tucson controlled
substance dispensings.\18\
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\18\ For example, Respondent's testimony admits that
testosterone pellets come in dosages ranging from 25 mg to 200 mg.
Tr. 309, 312. Her testimony also admits that liquid testosterone
``absolutely'' comes in different ``dosage bottles.'' Id. at 336. In
addition, some of Respondent's testimony admits that her records of
Tucson clinic testosterone and Phentermine dispensings do not
include the strength of the testosterone and Phentermine dispensed.
Id. at 320, 338. Elsewhere, however, Respondent's testimony states
that there is only one strength of testosterone pellets. Id. at 321-
22. Then, shortly after so testifying, Respondent again testifies
that testosterone pellets come in a range of strengths, and that
liquid testosterone ``absolutely'' comes in different ``dosage
bottles.'' Id. at 322, 336.
---------------------------------------------------------------------------
The Agency acknowledges that Respondent added at least the patient
addresses to her dispensing logs starting on November 10, 2023, ``after
. . . [her] deposition in November.'' \19\ RX D, at 23; Tr. 320. While
the inclusion of the required patient address is an improvement,
Respondent's dispensing logs still do not contain all of the required
elements, such as the strength of the dispensed controlled substance.
Supra. For the above reasons, the Agency finds substantial record
evidence that Respondent's ``updated'' dispensing logs continue not to
comply with the regulations.
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\19\ The Agency notes other differences between Respondent's
dispensing logs prior to and on November 10, 2023, but does not see
discussion of those differences in the hearing transcript. RX D, at
22-23. Regardless, the Agency finds substantial record evidence that
drug strength still is not noted on Respondent's RX D dispensing
logs. Id.; Tr. 321.
---------------------------------------------------------------------------
According to Respondent's tenth factual Exception, the RD
incorrectly characterizes Respondent's testimony as a concession that
her dispensing logs continue not to comply with the regulations.
Exceptions, at 15. She further argues that ``[t]o conclude that . . .
[Respondent's] updated logs are inadequate places form well over
substance,'' and that any failure on her
[[Page 16886]]
part is ``inconsequential.'' Id. at 16. As already discussed, the
Agency acknowledges that Respondent added the patient address to her
dispensing logs as of November 10, 2023. RX D, at 23. While the
inclusion of the required patient address is an improvement,
Respondent's dispensing logs still do not include all of the required
elements, such as the strength and the form of the dispensed controlled
substance. Id.; Tr. 321. For the above reasons, the Agency finds
substantial record evidence that Respondent's ``updated'' dispensing
logs in RX D continue not to comply with the regulations. The Agency
rejects Respondent's tenth factual Exception, and specifically
disagrees that Respondent's failures are ``inconsequential.''
Having read and analyzed all of the record evidence, the Agency
finds substantial record evidence that Respondent's Tucson clinic's
controlled substance dispensing logs, for the period germane to the
OSC/ISO, do not include the requisite data points. Supra.
IV. Discussion
A. The Controlled Substances Act and Implementing Regulations
Pursuant to the CSA, ``[t]he Attorney General shall register
practitioners . . . to dispense . . . controlled substances . . . if
the applicant is authorized to dispense . . . controlled substances
under the laws of the State in which he practices.'' 21 U.S.C.
823(g)(1). The section further provides that an application for a
practitioner's registration may be denied upon a determination that
``the issuance of such registration . . . would be inconsistent with
the public interest.'' Id. Congress directed the Attorney General to
consider five factors in making the public interest determination. 21
U.S.C. 823(g)(1)(A-E).\20\ Congress directed the Attorney General to
consider the same five factors when determining whether to suspend or
revoke a practitioner's registration due to the practitioner's
commission of ``such acts as would render his registration under . . .
[21 U.S.C. 823] inconsistent with the public interest.'' 21 U.S.C.
824(a)(4).
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\20\ The five factors of 21 U.S.C. 823(g)(1)(A-E) are:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
---------------------------------------------------------------------------
The five factors are considered in the disjunctive. Gonzales v.
Oregon, 546 U.S. at 292-93 (Scalia, J., dissenting) (``It is well
established that these factors are to be considered in the
disjunctive,'' citing In re Arora, 60 FR 4447, 4448 (1995)); Robert A.
Leslie, M.D., 68 FR 15,227, 15,230 (2003). Each factor is weighed on a
case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d 165, 173-74
(D.C. Cir. 2005). Any one factor, or combination of factors, may be
decisive. Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C.
Cir. 2007); Morall, 412 F.3d at 185 n.2; David H. Gillis, M.D., 58 FR
37,507, 37,508 (1993).
The Agency ``may rely on any one or a combination of factors and
may give each factor the weight [it] deems appropriate. Morall, 412
F.3d at 185 n.2; see also Jones Total Health Care Pharmacy, LLC v. Drug
Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi
v. Drug Enf't Admin., 841 F.3d 707, 711 (6th Cir. 2016)); Drug Enf't
Admin., 664 F.3d 808, 816 (10th Cir. 2011); Volkman U. S. Drug Enf't
Admin., 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin.,
419 F.3d 477, 482 (6th Cir. 2005). Moreover, while the Agency is
required to consider each of the factors, it ``need not make explicit
findings as to each one.'' MacKay, 664 F.3d at 816 (quoting Volkman,
567 F.3d at 222); see also Hoxie, 419 F.3d at 482. ``In short, . . .
the Agency is not required to mechanically count up the factors and
determine how many favor the Government and how many favor the
registrant. Rather, it is an inquiry which focuses on protecting the
public interest; what matters is the seriousness of the registrant's
misconduct.'' Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
Accordingly, as the Tenth Circuit has recognized, findings under a
single factor can support the revocation of a registration. MacKay, 664
F.3d at 821.
While the Agency considered all of the 21 U.S.C. 823(g)(1) factors
in this matter, the Agency finds that the Government's evidence in
support of its prima facie cases is confined to factors B and D.
Government's Closing Brief, at 12; OSC/ISO, at 2; see also RD, at
21.\21\
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\21\ The Government argues that Factor E includes a respondent's
candor and forthrightness with DEA investigators. Government's
Closing Brief, at 11; see also RD, at n.55. The Agency declines to
adopt the Government's Factor E arguments in this matter.
---------------------------------------------------------------------------
According to DEA regulations, the Government has the burden of
proof in this proceeding. 21 CFR 1301.44(d) (granting or denying an
application), 21 CFR 1301.44(e) (revoking or suspending a
registration). Both parties submitted documentary evidence. The Agency
agrees with the Chief ALJ's rulings on the admissibility of the offered
evidence.
B. Allegations That Respondent's Tucson Registration and Proposed GVC
Registration Are Inconsistent With the Public Interest
Factors B and/or D--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
The OSC/ISO alleges that Respondent violated multiple provisions of
the CSA and its implementing regulations concerning controlled
substance registration and recordkeeping requirements. These
registration and recordkeeping requirements go to the heart of federal
controlled substance law and this Agency's law enforcement mission.
Having thoroughly analyzed the record evidence and applicable law,
the Agency finds substantial record evidence that Respondent
administered controlled substances from an unregistered location, in
violation of 21 CFR 1301.12(a). Supra section III.A. Accordingly, the
Agency concludes that the Government presented a prima facie case that
Respondent dispensed controlled substances from GVC, an unregistered
location, and that Respondent tried, but failed, to rebut that prima
facie case. Id. Next, the Agency finds substantial record evidence that
Respondent failed to maintain, readily retrievable from her ordinary
business records, a complete and accurate record of each controlled
substance received at her Tucson clinic, in violation of 21 U.S.C.
827(a)(3) and 827(b) and 21 CFR 1304.04(a) and 1304.21(a). Supra
section III.B. Accordingly, the Agency concludes that the Government
presented a prima facie case that Respondent did not maintain, readily
retrievable from her ordinary business records at her Tucson clinic, a
complete and accurate record of each controlled substance received at
that clinic, and that Respondent tried, but failed, to rebut that prima
facie case. Id. Finally, the Agency finds substantial record evidence
that Respondent did not maintain the requisite controlled substance
dispensing logs, in violation of 21 CFR 1304.22(c). Supra section
III.C. Accordingly, the Agency concludes that the Government presented
a prima facie case that Respondent failed to maintain the requisite
controlled substance
[[Page 16887]]
dispensing logs, and that Respondent tried, but failed, to rebut that
prima facie case.
Accordingly, the Agency finds that Factors B and D weigh in favor
of revocation of Respondent's Tucson registration and denial of her GVC
application because her continued registration is inconsistent with the
public interest. 21 U.S.C. 824(a)(4) and 823(g)(1).
V. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Respondent's continued Tucson registration and her being
granted a registration for GVC are inconsistent with the public
interest, the burden shifts to Respondent to show why she can be
entrusted with a registration. Morall, 412 F.3d. at 174; Jones Total
Health Care Pharmacy, 881 F.3d at 830; Garrett Howard Smith, M.D., 83
FR 18,882 (2018). The issue of trust is necessarily a fact-dependent
determination based on the circumstances presented by the individual
respondent. Jeffrey Stein, M.D., 84 FR 46,968, 46,972 (2019); see also
Jones Total Health Care Pharmacy, 881 F.3d at 833. Moreover, as past
performance is the best predictor of future performance, DEA
Administrators have required that a registrant who has committed acts
inconsistent with the public interest must unequivocally accept
responsibility for those acts and demonstrate that she will not engage
in future misconduct. Jones Total Health Care Pharmacy, 881 F.3d at
831-33 (citing, among other authority, Alra Labs., Inc. v. Drug Enf't
Admin., 54 F.3d 450, 452 (7th Cir. 1995) (``An agency rationally may
conclude that past performance is the best predictor of future
performance.''). ``[T]hat consideration is vital to whether continued
registration is in the public interest,'' and the acceptance of
responsibility must be unequivocal. MacKay v. Drug Enf't Admin., 664
F.3d at 820, 830-31. Further, DEA Administrators have found that the
egregiousness and extent of the misconduct are significant factors in
determining the appropriate sanction. Id. at 834 and n.4. DEA
Administrators have also considered the need to deter similar acts by
the respondent and by the community of registrants. Jeffrey Stein,
M.D., 84 FR 46,972-73.
Regarding these matters, while Respondent stated, during her
hearing testimony, that she does not want to give the ``implication
that . . . [she is] not accepting responsibilities [sic],'' the Agency
finds substantial record evidence that she minimizes her unlawfulness.
For example, Respondent testified that she ``know[s] that . . . [she]
should have known . . . [the] regulations and had . . . [her] paperwork
in order.'' Tr. 354. She immediately affirms that she ``know[s] that
and it will happen.'' Id. She then immediately continues, apparently
even attempting to minimize her unlawfulness, stating that she ``was
not dealing with any other substance than testosterone and
Phentermine.'' \22\ Id.
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\22\ The Agency takes seriously the mishandling, abuse, and the
potential for abuse of testosterone and Phentermine.
---------------------------------------------------------------------------
In addition, the Agency finds substantial record evidence that
Respondent blames DEA staff for her unlawfulness. Even after having the
opportunity to improve by, for example, making her dispensing logs
legally compliant, she never fully complies with the requirements
incumbent on her as a registrant. Tr. 354. Instead, she shifts the
blame for her failure to comply with legal requirements. For example,
regarding her dispensing logs, she blames the DEA Investigators for not
giving her an exemplar. She testified that ``anytime . . . [she] had
interactions with diversion investigators, . . . [she] was never really
given a [dispensing] log. . . [I]t would be really easy and simple to
say, Svetlana, this is what needs to happen, and it would have happened
like in a matter of hours.'' Id. at 353.
Further, Respondent is unwilling, or unable, to understand the
responsibilities of a registrant, a matter with troubling
ramifications. For example, she does not know the meanings of
``administer'' and ``dispense,'' two terms defined in the CSA. 21
U.S.C. 802(2), 802(10). Supra sections II.A. and III.A. Instead of
citing the statutory meaning of those terms, she testified that ``[i]n
. . . [her] mind, dispensing is something that occurs with shipping to
you and you--you account for the drug in that location.'' Tr. 292
(emphasis added). Based on her incorrect definition of those terms, she
told the DEA Investigators that she was not ``dispensing'' from GVC, an
unregistered location. Id. at 291. Yet, her multiple testimonial and
documentary admissions belie her denial of dispensing controlled
substances at GVC. E.g., id. at 285, 297, 308; GX 13, GX 14. Thus, in
addition to her not being willing or able to understand the
responsibilities of a registrant, any DEA Investigator in the future,
based on the experience of the DEA Investigators who interacted with
Respondent in this matter, would not be able to trust the accuracy of
Respondent's statements.
Respondent's record testimony indicates that she did not understand
the reasons why the CSA and its implementing regulations require that
controlled substances only be dispensed from registered locations. For
example, Respondent ``didn't think that it would be a big deal at all''
to have controlled substances at GVC as she ``was under the impression
. . . [that her] license [was] coming any day, really.'' Tr. 305. The
Agency cannot entrust a registration to an individual who does not
think that it is a ``big deal'' to violate one of the foundational
principles of the CSA.
Accordingly, the Agency finds substantial record evidence that
Respondent did not unequivocally accept responsibility for her
unlawfulness.\23\ As such, Respondent has not convinced the Agency that
she can be entrusted with a registration.
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\23\ For all of the above reasons, the Agency does not agree
with Respondent's second legal Exception. Exceptions, at 20-24.
As the Agency does not consider remedial measures in the absence
of unequivocal acceptance of responsibility, the Agency does not
accept Respondent's third legal Exception. Exceptions, at 24.
---------------------------------------------------------------------------
The interests of specific and general deterrence weigh in favor of
the revocation of Respondent's Tucson registration and the denial of
her Green Valley registration application. The Agency finds substantial
record evidence that Respondent's testimony and controlled substance
records establish that she failed to comply, over an extended time
period, with registration and recordkeeping requirements that go to the
heart of federal controlled substance law. E.g., Tr. 354 (``I know that
I should have known my regulations and had my paperwork in order. I
know that, and it will happen.''); Tr. 291-92; supra n.11 (Respondent's
confusion about the meaning of ``dispense'' and her eighth factual
Exception). The principle of specific deterrence requires the Agency to
take action to deter Respondent who, despite over a decade of
experience as a registrant and multiple, recent interactions with, and
specific instructions from, DEA Investigators, continued to dispense
controlled substances from an unregistered location, among other
things. Tr. 260. Further, Respondent seemed not to take the DEA
inspection seriously as she testified that she is unaware of the
inspection's findings and whether the DEA Inspection Team received all
of the documents it requested. Supra section III.B. Respondent's
willing unawareness of the results of the inspection of her
[[Page 16888]]
Tucson clinic does not indicate Respondent's future compliance with the
CSA and the CSA's implementing regulations.
For all of the above reasons, it is not reasonable to rely on
Respondent's promise of her future compliance with the requirements
incumbent on a registrant. Given the foundational nature of
Respondent's violations, a sanction less than revocation would send a
message to her, and to the existing and prospective registrant
community, that compliance with the law is not a condition precedent to
maintaining a registration. E.g., Jones Total Health Care Pharmacy, 881
F.3d at 834 and n.4; Garrett Howard Smith, M.D., 83 FR 18,910
(collecting cases).
Accordingly, the Agency shall order the revocation of Respondent's
Tucson registration and the denial of her GVC application as contained
in the Order below.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a)(4) and 21 U.S.C. 823(g)(1), I hereby revoke DEA
Certificate of Registration No. MB2645767 issued to Svetlana Burtman,
N.P. Further, pursuant to 28 CFR 0.100(b) and the authority vested in
me by 21 U.S.C. 823(g)(1), I hereby deny the pending application,
Control No. W231061194M, of Svetlana Burtman, N.P., for registration in
Green Valley, Arizona.
In addition, pursuant to 28 CFR 0.100(b) and the authority vested
in me by 21 U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby deny any
pending application to renew or modify DEA Certificate of Registration
No. MB2645767, as well as any other pending application of Svetlana
Burtman, N.P., for registration in Arizona. This Order is effective May
22, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 16, 2025, by Acting Administrator Derek Maltz. That document with
the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-06882 Filed 4-21-25; 8:45 am]
BILLING CODE 4410-09-P